Description

Overview:

The opportunity to design a total quality management from scratch offers great rewards in experiencing and understanding the functions of quality systems. For me, this “dream” of building the “perfect quality system” began during my early quality management days as I learned and experienced quality system successes and failures. I learned from these thinking and dreaming, “If only I could set up my own quality system”.

Finally, this dream came true when I was given the opportunity to design and implement a combination pharmaceutical and medical device quality system from scratch. Since this first experience, I have designed and implemented several quality systems (including virtual) that have resulted in successful preapproval inspections. I have also revamped failing quality systems to make them more compliant and effective.

As you can imagine, starting from scratch and revamping failing systems is hard work, but the experience and knowledge gained is extremely valuable. The relationships built, both positive and negative, will last forever. I want to share these experiences with you so that you may gain insight about the hard work, expectations, pitfalls, and the rewards of starting a system from scratch.

Why Should You Attend:

• For those facing the challenge of developing a quality system, this webinar provides very valuable insights and practical advice that can be applied to their quality system development
• For those with existing quality systems, this webinar provides insights and information that may be used to improve or remediate your quality system
Areas Covered in this Webinar
I.Introduction, purpose, and objectives
II.Defining the status quo. Where am I right now and where do I want to go
III.Defining the scope of the quality system and planning
IV.The Employee – competent, qualified, dedicated, & trained for advancement
V. Planning & developing the quality assurance manual requires multi-functional involvement and dedication and, most important, the conscious effort to a commitment of working together for the good of the organization
VI.The Technical manual captures the technology and technical requirements and may be considered as a separate entity or as part of the quality manual
VII.Understanding and planning facility and equipment requirements based on the facility and equipment lifecycle and manufacturing cycle
VIII.Materials must meet requirements so that the facility and equipment has the capability to produce consistent and predictable products
IX.Developing the master record begins in product development and culminates at the end of design at which time it represents the “HOW” for manufacturing the product with consistent and predictable quality that meets customer requirements
X.Maintaining and improving the quality system – the economics of quality systems

Learning Objectives:

• To provide an overview of all the factors and nuances that influence the development of the quality system
• To provide insight so that a person or organization can gain a perspective on their current situation in order to begin planning for developing and implementing a quality system
• To provide some very practical methods and ways to design and develop and implement a more effective quality system
• To provide examples from the many years of experience the speaker has in designing, developing, and implementing quality systems from the ground floor.